Label: RASH RELIEF ANTIBACTERIAL- bacitracin dimethicone zinc oxide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 15071-672-11, 15071-672-22 - Packager: Touchless Care Concepts LLC
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 16, 2011
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
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Warnings
- Do not use over deep or puncture wounds, infections, or lacerations. Do not apply over large areas of the body.
- When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water. For external use only.
- Stop use and ask a doctor if condition worsens or does not improve in 7 days..
- Directions
- Inactive Ingredients
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RASH RELIEF ANTIBACTERIAL
bacitracin dimethicone zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:15071-672 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Bacitracin (UNII: 58H6RWO52I) (Bacitracin - UNII:58H6RWO52I) Bacitracin 500 [iU] in 1 g Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone 20 g in 100 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 25 g in 100 g Inactive Ingredients Ingredient Name Strength Cyclomethicone (UNII: NMQ347994Z) Mineral Oil (UNII: T5L8T28FGP) Lanolin (UNII: 7EV65EAW6H) Microcrystalline Wax (UNII: XOF597Q3KY) Hexamethyldisiloxane (UNII: D7M4659BPU) Water (UNII: 059QF0KO0R) Cholecalciferol (UNII: 1C6V77QF41) Vitamin a palmitate (UNII: 1D1K0N0VVC) Petrolatum (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:15071-672-11 28 g in 1 BOTTLE 2 NDC:15071-672-22 44 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 06/14/2006 Labeler - Touchless Care Concepts LLC (083459334) Registrant - Touchless Care Concepts LLC (083459334)